L-arginine for Knee Osteoarthritis Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: L-arginine tablet, Placebo tablet.
- Who it may be relevant to
- Registry conditions: Osteoarthritis, Knee. Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Oral L-Arginine for Pain Relief in Knee Osteoarthritis: a Randomized, Double-Blind, Placebo-Controlled Trial
Overview
This study will examine the pain-relief efficacy and safety of L-arginine in knee OA patients.
Detailed description
Pain is the dominant symptom of knee osteoarthritis (KOA). The main management goal for people with KOA is to control pain without increasing treatment-related adverse effects (AEs). However, the commonly prescribed systemic analgesics have safety concerns, such as increased risk of cardiovascular and gastrointestinal AEs. Therefore, it is urgent to develop safe and effective treatment options.
L-arginine is one of the most commonly used oral nutritional supplements that has been widely used in patients with peripheral arterial disease, cystic fibrosis, and pregnant women with high risk of pre-eclampsia. The supplement has a high safety profile. Previous case-control and cross-sectional studies have found plasma L-arginine levels were lower in patients with knee OA than controls, suggesting that arginine deficiency may increase the risk of OA. The investigators previously observed an inverse dose-response relationship between levels of serum L-arginine and the risk of incident symptomatic KOA. Additionally, the investigators demonstrated that intra-articular injection of L-arginine solution relieved pain symptoms in a surgical rat model of OA. However, there is a paucity of high-quality clinical evidence on the effect of intake of L-arginine supplement on pain relief among patients with symptomatic KOA.
The investigators propose to conduct a randomized, double-blind, placebo-controlled trial to examine the efficacy and safety of oral L-arginine in patients with knee OA.
Interventions
- Dietary supplement L-arginine tablet
L-arginine, 2 g, three times daily, for 12 weeks - Dietary supplement Placebo tablet
Identical inert placebo, three times daily, for 12 weeks
Primary outcome measures
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score. [Time frame: Baseline, Week 12]
Secondary outcome measures (12)
- Change From Baseline in WOMAC pain score. [Time frame: Baseline, Weeks 2, 4 and 8]
- Change From Baseline in Knee pain on a visual analogue scale (VAS). [Time frame: Baseline, Weeks 2, 4, 8 and 12]
- Change From Baseline in WOMAC total score. [Time frame: Baseline, Weeks 2, 4, 8 and 12]
- Change From Baseline in Change From Baseline in WOMAC stiffness score. [Time frame: Baseline, Weeks 2, 4, 8 and 12]
- Change From Baseline in WOMAC function score. [Time frame: Baseline, Weeks 2, 4, 8 and 12]
- Change From Baseline in Patient global assessment of osteoarthritis (PGA-OA) score. [Time frame: Baseline, Weeks 2, 4, 8 and 12]
- Change From Baseline in SF-12 questionnaire score. [Time frame: Baseline, Weeks 2, 4, 8 and 12]
- Change From Baseline in Timed Up and Go Test (TUG). [Time frame: Baseline, Weeks 4, 8 and 12]
- Change From Baseline in Chair-stand Test. [Time frame: Baseline, Weeks 4, 8 and 12]
- Change From Baseline in Ultrasound-assessed knee synovitis. [Time frame: Baseline, Week 12]
- Rescue medicine consumption. [Time frame: Weeks 2, 4, 8 and 12]
- Change From Baseline in Level of C-reactive protein (CRP). [Time frame: Baseline, Weeks 4, 8 and 12]
Eligibility criteria
Inclusion criteria
- Age between 40 and 80 years.
- Knee OA according to the American College of Rheumatology (ACR) clinical criteria.
- Knee pain lasting 3 months or longer and a score of 7 or greater on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (standardized to range from 0-20).
- Kellgren-Lawrence (KL) grade 2 or 3.
- Willing to and able to provide written informed consent.
Exclusion criteria
- Any use of NSAIDs or other analgesics in the past two weeks.
- History of injections of corticosteroids in the past three months or hyaluronic acid in the past 6 months in the index knee.
- History of arthroscopy or open surgery in the index knee in the past 12 months.
- History of a knee replacement in the index knee or planning to receive such a procedure within 3 months.
- History of a severe injury in the index knee.
- Pain in the index knee caused by inflammatory, autoimmune, neoplastic diseases or other diseases.
- Abnormal liver or kidney functions, as defined by alanine transaminase or aspartate aminotransferase >two times the upper limit of normal, or blood urea nitrogen or serum creatinine >two times the upper limit of normal.
- Severe respiratory diseases.
- History of coronary artery disease and heart failure.
- Uncontrolled hypertension or diabetes mellitus.
- Diagnosis of malignant tumors.
- Pregnant or contemplating pregnancy or breast-feeding.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Xiangya Hospital — Changsha
Identifiers
NCT: NCT06054633 · 20230608